Safety and Activity Study of PSCA-Targeted CAR-T Cells (BPX-601) in Subjects With Selected Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and activity of BPX-601 CAR-T cells in participants with previously treated advanced solid tumors (pancreatic and prostate) expressing high levels of prostate stem cell antigen (PSCA). Participants' T cells are modified to recognize and target the PSCA tumor marker on cancer cells.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bellicum Pharmaceuticals

Criteria

Inclusion Criteria:

• Metastatic pancreatic cancer with tumor progression within 6 months of the most recent anti-cancer treatment and documented positive tumor expression of PSCA, and prior treatment with first or second-line therapy; or,

• Metastatic castration-resistant prostate cancer (mCRPC), with progressive disease per PCWG3 criteria during or following the direct prior line of therapy.

• Measurable disease per RECIST v1.1 at baseline; subjects with mCRPC with bone only metastases must have measurable PSA.

• Age ≥18 years.

• Life expectancy > 12 weeks.

• ECOG 0-1

• Adequate organ function.

Exclusion Criteria:

• Pancreatic cancer with islet cell neoplasms or symptomatic/untreated coagulopathy.

• Prostate cancer with unstable bone lesions or symptomatic/untreated coagulopathy, or history of > Grade 2 hematuria within the previous 6 months.

• Prior CAR T cell or other genetically-modified T cell therapy. Prior treatment with an immune-based therapy for the treatment of prostate cancer, including cancer vaccine therapies are allowable.

• Symptomatic, untreated, or actively progressing central nervous system metastases.

• Impaired cardiac function or clinically significant cardiac disease.

• Pregnant or breastfeeding.

• Participant requires chronic, systemic steroid therapy.

• Severe intercurrent infection.

• Known HIV positivity.